MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367964
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes experienced erroneous results.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated "lab manager called into see if anyone has reported experiencing erroneous results with product 367964, lot 0100300.She has experienced potassium levels greater than 10 and calcium levels less than one.No samples are available.Unsure of medical intervention.23-nov-2020: "customer states it happened 6 times with different phlebotomists on different floors.She states the order of draw is correct, and when the patient is re-drawn, the k and ca are normal.I informed her that if the contents of the edta tube are poured into the pst tube, you can see these erroneous results.She stated that her phlebotomists did not do this." 24-nov-2020: customer response, - "no erroneous results.Condition of sample is good.Order of draw: confirmed on at least one patient that the lavender drawn last.Unknown on the rest.Specimens were left 10-20 mins before centrifugation.A swing bucket was used.Potassium was run.Normal ranges of potassium are 3.5-5.1.Patient's results were greater than 10.0.Test were repeated on red sst from same draw with normal values.".
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was able to confirm the reported condition in the clinical testing conducted.The customer¿s reported concern was replicated in a single retain sample.In addition, retention samples were tested for additive abnormalities.All testing was within specification with no abnormalities identified.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for erroneous results based on the clinical testing performed.A root cause could not be determined.
Event or Problem Description
It was reported the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes experienced erroneous results.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated "lab manager called into see if anyone has reported experiencing erroneous results with product 367964, lot 0100300.She has experienced potassium levels greater than 10 and calcium levels less than one.No samples are available.Unsure of medical intervention.23-nov-2020: "customer states it happened 6 times with different phlebotomists on different floors.She states the order of draw is correct, and when the patient is re-drawn, the k and ca are normal.I informed her that if the contents of the edta tube are poured into the pst tube, you can see these erroneous results.She stated that her phlebotomists did not do this." 24-nov-2020: customer response, - "no erroneous results.Condition of sample is good.Order of draw: confirmed on at least one patient that the lavender drawn last.Unknown on the rest.Specimens were left 10-20 mins before centrifugation.A swing bucket was used.Potassium was run.Normal ranges of potassium are 3.5-5.1.Patient's results were greater than 10.0.Test were repeated on red sst from same draw with normal values.".

• Brand Name: BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11006106
• Report Number: 1917413-2020-01226
• Device Sequence Number: 19737401
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2021
• Device Model Number: 367964
• Device Catalogue Number: 367964
• Device Lot Number: 0100300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1